Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02323750
Eligibility Criteria:
Inclusion Criteria:
* Asymptomatic systolic dysfunction (defined as: ejection fraction \< 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit)
* A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit
* No heart failure symptoms (NYHA II, III or IV) upon inclusion
* 6MWD ≥ 80% of reference values
* Written informed consent
* Age ≥ 18 years
Exclusion Criteria:
* Symptomatic heart failure (NYHA\>I) at baseline visit
* Any significant valvular disease (\> 2nd degree)
* Severe pulmonary disease (e.g. FEV1/FVC \<0.7 and FEV1\<50%)
* Severe renal disease (GFR \< 15 ml/min)
* ejection fraction at baseline visit ≥ 50% by echocardiography or MRI
* Life expectancy \< 1 year
* Pericardial disease
* Hypertrophic cardiomyopathy
* Myocardial infarction within the last 3 months
* Planned cardiac surgical intervention within 3 months after inclusion
* Geographical reasons (e. g. patients living outside Germany or planning to move abroad)
* Inability to give informed consent (e. g. mental disorders)
* Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02323750
Study Brief:
Protocol Section:
NCT02323750